AUD Biomarkers Study (Proteomic and Genomic Analysis of Biospecimens)

Launched by AUDUBON BIOSCIENCE · Jun 2, 2023

Keywords

ClinConnect Summary

The primary objective of this Study is to collect high-quality tissue, whole teeth, and biofluid Specimens, and associated Clinical Data from consented Subjects.

The secondary objective of this Study is to test Specimens and associated Clinical Data to confirm pathology diagnosis and correlation of microscopic evaluation with the provided information, to assess RNA and DNA integrity or degradation, and provide overall quality control evaluations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject shall be at least 18 years of age, or higher if required by Applicable Law.
• • 2. Subject's Clinical Data shall be relevant to the Study in which he/she is participating.
• • 3. Subject shall understand and voluntarily sign the ICF prior to the Study participation. If the Subject is illiterate, the witness must sign the ICF (see 5.6. for details). If the Subject is incapable of consenting himself/herself, the legally authorized representative must sign the ICF (see 5.6. for details).
• • 4. Subject shall meet any other additional inclusion criteria specified in Appendices to this Protocol, or in additional written instructions of the Sponsor.
• • 5. Subject shall be able to donate the requested Specimen(s) without compromising his/her current health status.
• Exclusion Criteria:
• • 1. Younger than 18 years of age, or higher if required by Applicable Law.
• • 2. The individual is incapable of understanding the items listed in the ICF and the consent process unless consented by the legally authorized representative.
• • 3. Prisoner